Medical apparatus with hypopharyngeal suctioning capability

ABSTRACT

A laryngeal mask apparatus includes a mask portion, a breathing tube and a suction tube. The suction tube is adapted for connection to a suction-producing device. The suction tube further includes suction ports that suck fluids and secretions from the patient&#39;s hypopharyngeal region when suction is created within the interior of the suction tube. The breathing tube is adapted for connection to a ventilating system. Air flows through the breathing tube and into the mask portion. A capillary tube is positioned within the interior of the suction tube. When the mask portion is positioned within a patient&#39;s throat and suction is created within interior of the suction tube, the suction ports suck the fluids and secretions in the patient&#39;s hypopharyngeal region. At the same time, the suction tube and capillary tube cooperate to provide a stream of air that decreases the direct suction forces on the mucosa of the patient&#39;s throat that are caused by the suction ports. The laryngeal mask apparatus includes a scope tube having an interior and an inner tube disposed within the interior of the scope tube. The inner tube is sized for receiving a gastric tube.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional application No.62/617,161, filed Jan. 12, 2018.

This application is also a continuation-in-part of U.S. application Ser.No. 15/023,371, filed Mar. 19, 2016, which is a National Stageapplication of international application No. PCT/US2014/057059, filedSep. 23, 2014, which is a continuation-in-part of U.S. application Ser.No. 13/359,473, filed Jan. 26, 2012, now U.S. Pat. No. 9,687,622, whichis a divisional application of U.S. application Ser. No. 11/817,606,filed Aug. 31, 2007, now U.S. Pat. No. 8,105,316, which is the NationalStage of international application No. PCT/US2006/010623, filed Mar. 23,2006, which claims the benefit of U.S. provisional application No.60/665,585, filed Mar. 25, 2005. The entire disclosures of applicationNos. 62/617,161, 15/023,371, 13/359,473, 11/817,606, PCT/US2006/010623and No. 60/665,585 are hereby incorporated by reference. The entiredisclosures of U.S. Pat. Nos. 8,105,316 and 9,687,622 are herebyincorporated by reference.

TECHNICAL FIELD

The present invention generally relates to nasogastric tubes andlaryngeal masks.

BACKGROUND ART

Nasogastric tubes and related devices are described in U.S. Pat. Nos.5,643,230, 5,417,664, 5,011,474, 5,000,175, 4,821,715, 4,787,894,4,735,607, 4,699,138, 4,508,533, and 4,214,593. Nasogastric tubes andrelated devices are also described in the following patents andpublished patent applications: EP 0500778, JP 10179677, WO 9716154, WO9631248, and WO 8000538.

Nasogastric tubes are used to aspirate food contents from the stomach orto feed patients who are unable to safely feed themselves. Nasogastrictubes are commonly used in the operating room, intensive care units,home care, and in hospice settings. Prior art nasogastric tubes arefrequently used to aspirate stomach contents. However, in some cases,aspiration of the stomach contents results in micro-aspirations that cancause nosocomial infections.

Similar problems can occur with prior art laryngeal masks. Laryngealmasks are used to provide ventilation and are commonly used in theoperating room and in situations where it is difficult to insert anendotracheal tube. Prior art laryngeal masks and related devices aredescribed in U.S. Pat. Nos. 4,351,328, 4,509,514, 4,995,388, 5,241,956,5,303,697, 5,355,879, 5,632,271, 5,878,745, 6,631,720 and 6,895,966 andin published international patent application No. WO 1994/02191. Adisadvantage of prior art laryngeal masks is that there is no protectionfrom aspiration into the lungs of gastric contents or salivaregurgitated into the hypopharynx and pharynx.

DISCLOSURE OF THE INVENTION

The present invention is directed to, in one aspect, a medical apparatuscomprising a nasogastric tube with hypopharyngeal suctioning capability.An important feature of the medical apparatus of the present inventionis that it includes a suction intake in the area of the hypopharynxwhich effects capturing microaspirations as well as larger regurgitatedmaterial that reaches the hypopharynx. A significant advantage of thepresent invention is that it reduces infection rates in intubatedpatients.

In one aspect, the present invention is directed to laryngeal maskapparatus (2000) comprising a mask (2001) comprising a front side (2002)and a rear side (2004) that faces the back of a patient's throat whenthe mask (2001) is positioned within a patient's throat. The mask (2001)include an inflatable tubular ring (2005) and an inner spatial region(2005A) that is surrounded by the inflatable tubular ring (2005). Themask (2001) has a front end (2007) and an opening in front end (2007)which extends to the inner spatial region. The laryngeal mask apparatus(2000) further includes an air tube (2012) that is connected to theinflatable tubular ring (2005) and adapted to be connected to an airsource to enable inflation of the inflatable tubular ring (2005). Ajoint section (2006) is attached to the rear side (2004) of mask (2001)and has an exterior surface. A flexible breathing tube (2010) isconnected to the joint section (2006). The flexible breathing tube(2010) has an interior (2011) for the flow of air therethrough, whereinair in flexible breathing tube (2010) can flow through the flexiblebreathing tube (2010) and through the joint section (2006) and into themask (2001). The flexible breathing tube (2010) includes a portionconfigured for connection to a ventilating system. An additionalflexible tube (2018) is attached to the exterior surface of the flexiblebreathing tube (2010) and has an interior (2019), a first portion(2018A) and a second portion (2018B) that is configured to be connectedto a suction producing device that produces suction within interior(2019). A portion of first portion (2018A) is wrapped about and attachedto the exterior surface of joint section (2006), wherein the additionalflexible tube (2018) extends to a distal end (2018C). The distal end(2018C) is part of first portion (2018A). The first portion (2018A) hasa plurality of suction ports (2009) in communication with the interior(2019) of additional flexible tube (2018). The suction ports (2009) arelocated in the first portion (2018A) such that the suction ports (2009)face the back of the patient's throat when the mask (2001) is positionedwithin a patient's throat so that the suction ports (2009) suck influids and secretions in a patient's hypopharyngeal region when suctionis created within interior (2019). The additional flexible tube (2018)further comprises an air entry hole (2050) in the second portion (2018B)and an air exit hole (2060) in the first portion (2018A). The section offirst portion (2018A) that has the distal end (2018C) and the air exithole (2060) is not attached to the exterior surface of joint section(2006) or mask (2001) but is spaced apart from mask (2001) to ensurethat the air exit hole (2060) is not blocked by any portion of the mask(2001). The additional flexible tube (2018) includes a flexible aircapillary tube (2020) that is positioned within the interior (2019) ofadditional flexible tube (2018) and which extends for substantially theentire length of the additional flexible tube (2018). The air capillarytube (2020) has a first open end in communication with the air entryhole (2050) and an opposite second open end in communication with theair exit hole (2060). When suction is created within interior (2019),air is drawn into air entry hole (2050) and enters first open end of aircapillary tube (2020) wherein the air then flows through air capillarytube (2020), exits the opposite second open end and then exits air exithole (2060), such that when the mask (2001) is positioned within apatient's throat and suction is created within interior (2019), the airexiting air exit hole (2060) decreases the direct suction forces on themucosa of the patient's throat that are caused by suction ports (2009).The laryngeal mask apparatus (2000) further includes a scope tube (2500)attached to the flexible breathing tube (2010) and having a first endthat is attached to the joint section (2006) and an opposite second end.The scope tube (2500) includes an interior and an inner tube (2510) thatis disposed within the interior of the scope tube (2500). The inner tube(2510) extends through the scope tube (2500) and inner spatial region(2005A) and is joined to the opening (2008) in the front end (2007) ofthe mask (2001). The inner tube (2510) is sized for the passagetherethrough of a gastric tube.

In accordance with one embodiment of the invention, the medicalapparatus comprises a flexible nasogastric tube for insertion through apatient's nose. The nasogastric tube has a first end and a distal,second end that defines an opening. The nasogastric tube has a lengthsufficient to allow the opening to be positioned in a patient's stomach.The medical apparatus further comprises a flexible oropharyngeal tubefor insertion through a patient's mouth. The oropharyngeal tube has afirst end and a distal, second end that defines a suction intake. Theoropharyngeal tube has a length that is less than the length of thenasogastric tube and which allows the suction intake to be positioned ina patient's hypopharynx region. The medical apparatus further comprisesa section of tube joined to and in communication with the flexiblenasogastric and oropharyngeal tubes. The section of tube is configuredto be joined to a suction apparatus that creates suction within theoropharyngeal tubes. This suction causes microaspirations andregurgitated material in the hypopharynx region to be sucked into thesuction intake of the oropharyngeal tube.

In another aspect, the present invention is related to a medicalapparatus comprising a laryngeal mask and a suction tube attached to thelaryngeal mask. The suction tube includes a plurality of suction portsor intakes that suck oropharyngeal secretions from the patient's mouthand the back of the patient's throat. Thus, in one embodiment, thismedical apparatus comprises a laryngeal mask having a front side andrear side wherein the rear side faces the back of a patient's throatwhen the laryngeal mask is used in a patient, and a flexible suctiontube attached to and extending along the rear side of the laryngealmask. The suction tube comprises a plurality of suction ports or intakesfor suctioning oropharyngeal secretions from the patient's mouth andback of the patient's throat and has an opening that is configured to beconnected to an apparatus for producing suction within the flexiblesuction tube.

In a further aspect, the present invention is directed to a laryngealmask apparatus (1000) for facilitating ventilation of a patient,comprising a mask (1001) comprising a front side (1002) and a rear side(1004) that faces the back of a patient's throat when the mask (1001) ispositioned within a patient's throat, and a flexible breathing tube(1010) that has an interior (1011) for the flow of air. The flexiblebreathing tube (1010) is in communication with the mask (1001). A jointsection (1006) is attached to the rear side (1004) of the mask portion(1001). The flexible breathing tube (1010) is connected to the jointsection (1006) so that air in flexible breathing tube (1010) can flowthrough the joint section (1006) and into the mask (1001). The flexiblebreathing tube (1010) is configured for use with a ventilating system.The laryngeal mask apparatus (1000) further comprises an additionalflexible tube (1018) comprising an interior (1019), a first portion(1018A) and a second portion (1018B) that is configured to be connectedto a device that facilitates creation of suction within interior (1019).A substantial portion of first portion (1018A) is joined or attached tothe exterior surface of joint section (1006). The additional flexibletube (1018) extends to a distal end (1018C) which is part of the firstportion (1018A). The first portion (1018A) has a plurality of suctionports (1009) in communication with the interior (1019). The suctionports (1009) are located on the first portion (1018A) such that thesuction ports (1009) face the back of the patient's throat when the mask(1001) is positioned within a patient's throat so that the suction ports(1009) suck in fluids and secretions in a patient's hypopharyngealregion when suction is created within interior (1019). The additionalflexible tube (1018) further comprises an air entry hole (1050) in thesecond portion (1018B) and an air exit hole (1060) in the first portion(1018A). The section of first portion (1018A) having distal end (1018C)and air exit hole (1060) is not joined or attached to joint section(1006) or rear side (1004) of mask (1001), but instead is spaced apartfrom mask (1001) such that air exit hole (1060) is not blocked by mask(1001). The additional flexible tube (1018) further comprises a flexibleair capillary tube (1020) that is located within the interior (1019) ofadditional flexible tube (1018). The flexible air capillary tube (1020)includes a first open end (1020A) that is in communication with the airentry hole (1050) and a second open end (1020B) that is in communicationwith the air exit hole (1060). When suction is created within interior(1019), air is drawn into air entry hole (1050) and enters first openend (1020A) of air capillary tube (1020) wherein the air then flowsthrough air capillary tube (1020), exits second open end (1020B) andthen exits air exit hole (1060), whereby when the mask (1001) ispositioned within a patient's throat and suction is created withininterior (1019), the air exiting air exit hole (1060) decreases thedirect suction forces on the mucosa of the patient's throat.

In one embodiment, the aforementioned substantial portion of firstportion (1018A) is also joined or attached to the rear side (1004) ofmask (1001).

The additional tube (1018) has a middle portion that is between firstportion (1018A) and the second portion (1018B). The middle portion isjoined or attached to the flexible breathing tube (1010).

The laryngeal mask apparatus (1000) further comprises a suction tubeconnector (1024) that is connected to the second portion (1018B) ofadditional flexible tube (1018). The suction tube connector (1024)further comprises a suction enablement device (1025) to enable creationof suction within interior (1019).

Mask (1001) further comprises an inflatable tubular ring (1005). Thelaryngeal mask apparatus (1000) further comprises an air tube (1012)that is connected to the inflatable tubular ring (1005) and, whenconnected to an air source, provides an air stream that inflatesinflatable tubular ring (1005). The laryngeal mask apparatus (1000)further comprises a connector (1026) that has a first portion (1028)that is inserted into the flexible breathing tube (1010) and a secondportion (1030) that is configured for connection to a ventilating systemthat provides air or oxygen or anesthesia.

In a further aspect, the present invention is directed to a laryngealmask apparatus (1000) for facilitating ventilation of a patient,comprising a mask (1001) that comprises a front side (1002) and a rearside (1004) that faces the back of a patient's throat when the mask(1001) is positioned within a patient's throat. The laryngeal maskapparatus (1000) further comprises a flexible breathing tube (1010)having an interior (1011) for the flow of air, and a joint section(1006) that is joined or attached to the rear side (1004) of the mask(1001). The flexible breathing tube (1010) is connected the jointsection (1006) so that air in the flexible breathing tube (1010) flowsthrough the joint section (1006) and into the mask (1001). The flexiblebreathing tube (1010) is configured for use with a ventilating system.The laryngeal mask apparatus (1000) further comprises an additionalflexible tube (1018) that comprises an interior (1019), a first portion(1018A) and a second portion (1018B) that is configured to be connectedto a device that facilitates creation of suction within interior (1019).A substantial portion of first portion (1018A) is joined or attached tothe exterior surface of joint section (1006). The additional flexibletube (1018) extends to a distal end (1018C) which is part of the firstportion (1018A). The first portion (1018A) has a plurality of suctionports (1009) in communication with the interior (1019). The suctionports (1009) are located on the first portion (1018A) at particularpositions such that the suction ports (1009) face the back of thepatient's throat when the mask (1001) is positioned within a patient'sthroat so that the suction ports (1009) suck in fluids and secretions ina patient's hypopharyngeal region when suction is created withininterior (1019). The additional flexible tube (1018) further comprisesan air entry hole (1050) in the second portion (1018B) and an air exithole (1060) in the first portion (1018A). The additional flexible tube(1018) further comprises a flexible air capillary tube (1020) that islocated within the interior (1019) of additional flexible tube (1018).The flexible air capillary tube (1020) includes a first open end (1020A)that is located so that it is near the air entry hole (1050) and asecond open end (1020B) that is located so that it is near the air exithole (1060). When suction is created within interior (1019), air isdrawn into air entry hole (1050) and enters first open end (1020A) ofair capillary tube (1020) wherein the air then flows through aircapillary tube (1020), exits second open end (1020B) and then exits airexit hole (1060), whereby when the mask (1001) is positioned within apatient's throat and suction is created within interior (1019), the airexiting air exit hole (1060) decreases the direct suction forces on themucosa of the patient's throat. In one embodiment, the aforementionedsubstantial portion of first portion (1018A) is also joined or attachedto rear side (1004) of mask (1001). In one embodiment, the additionalflexible tube (1018) has a middle portion that is between first portion(1018A) and the second portion (1018B). The middle portion is joined orattached to the flexible breathing tube (1010).

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the invention are believed to be novel. The figures arefor illustration purposes only and are not drawn to scale. The inventionitself may best be understood by reference to the detailed descriptionwhich follows taken in conjunction with the accompanying drawings inwhich:

FIG. 1 is a diagrammatic view, generally in side elevation, of a medicalapparatus in accordance with one embodiment of the invention, the samebeing shown used in a patient;

FIG. 2 is a diagrammatic view, generally in side elevation, of a medicalapparatus in accordance with another embodiment of the invention, thesame being shown used in a patient;

FIG. 3A is a diagrammatic view, generally in side elevation, of amedical apparatus in accordance with another embodiment of theinvention, the same being shown used in a patient;

FIG. 3B is a cross-sectional view of the tube structure shown in FIG.3A;

FIG. 3C is an enlarged view of a portion of the view of FIG. 3A;

FIG. 3D is an elevational view of a portion of the tube structure shownin FIG. 3A;

FIG. 4 is a perspective view of a medical apparatus in accordance withanother embodiment of the invention;

FIG. 5 is a plan view of the front side of a suction tube depicted inFIG. 4;

FIG. 6 is a plan view of the rear side of the suction tube shown in FIG.5;

FIG. 7 is a diagrammatic view of the medical apparatus of FIG. 4 used ina patient;

FIG. 8 is a diagrammatic view, generally in side elevation, of a medicalapparatus in accordance with a further embodiment of the invention, thesame being shown used in a patient;

FIG. 9 is an enlarged view of a portion of the view shown in FIG. 8;

FIG. 10 is an enlarged view of a portion of the view shown in FIG. 8;

FIG. 11 is an elevational view of a medical apparatus in accordance withanother embodiment of the invention;

FIG. 12 is a cross-sectional view taken along line 12-12 in FIG. 11;

FIG. 13 is side view of a laryngeal mask apparatus in accordance withanother embodiment of the invention;

FIG. 14A is cross-sectional view taken along line 14A-14A in FIG. 13;

FIG. 14B is a cross-sectional view of a flexible breathing tube andflexible tube structure in accordance with an alternate embodiment ofthe invention;

FIG. 14C is a view of a flexible air capillary tube that is shown inFIG. 14A;

FIG. 15 is a bottom view of the laryngeal mask apparatus;

FIG. 16A is a side view of a mouthpiece shown in FIG. 15;

FIG. 16B is a view taken along line 16B-16B in FIG. 16A;

FIG. 17 is an end view of the laryngeal mask apparatus;

FIG. 18 is a top view of the laryngeal mask apparatus;

FIG. 19 is an enlarged view of a portion of the view of FIG. 18;

FIG. 20 is a perspective view of the front side of the mask portion ofthe laryngeal mask apparatus;

FIG. 21 is a cross-sectional view taken along line 21-21 of FIG. 17;

FIG. 22 is a perspective view of the laryngeal mask apparatus;

FIG. 23 is a side view of the suction connector depicted in FIG. 13;

FIG. 24 is an enlarged, side view of a pilot valve and connectordepicted in FIGS. 15, 18 and 22; and

FIG. 25 is a perspective view of a laryngeal mask apparatus inaccordance with another embodiment of the present invention;

FIG. 26 is another perspective view of the laryngeal mask apparatus ofFIG. 25;

FIG. 27 is yet another perspective view of the laryngeal mask apparatusof FIG. 25;

FIG. 28 is another perspective view of the laryngeal mask apparatus ofFIG. 25;

FIG. 29 is an elevational view of the rear of the laryngeal maskapparatus of FIG. 25;

FIG. 30 is an elevational view of the front of the laryngeal maskapparatus of FIG. 25;

FIG. 31 is an elevational view of a first side of the laryngeal maskapparatus of FIG. 25;

FIG. 32 is an elevational view of an opposite second side of thelaryngeal mask apparatus of FIG. 25;

FIG. 33 is a view of one end of the laryngeal mask apparatus of FIG. 25;

FIG. 34 is a view of the opposite end of the laryngeal mask apparatus ofFIG. 25; and

FIG. 35 is a cross-sectional view taken along line 35-35 of FIG. 31.

DETAILED BEST MODE FOR CARRYING OUT THE INVENTION

It is to be understood that throughout this description, terms such as“vertical”, “horizontal”, “top”, “bottom”, “upper”, “lower”, “middle”,“above”, “below”, and the like are used for convenience in identifyingrelative locations of various components and surfaces relative to oneanother in reference to the drawings and that the medical apparatus maybe installed and used in substantially any orientation so that theseterms are not intended to be limiting in any way. Approximatinglanguage, as used herein throughout the specification and claims, may beapplied to modify any quantitative representation that could permissiblyvary without resulting in a change in the basic function to which it isrelated. Accordingly, a value modified by a term or terms, such as“about”, are not limited to the precise value specified.

As used herein, the terms “comprises”, “comprising”, “includes”,“including”, “has”, “having” or any other variation thereof, areintended to cover a non-exclusive inclusion. For example, a process,method, article or apparatus that comprises a list of elements is notnecessarily limited to only those elements, but may include otherelements not expressly listed or inherent to such process, method,article or apparatus.

Referring to FIG. 1, there is shown a diagrammatic view of oneembodiment of the medical apparatus of the present invention. Thismedical apparatus, generally indicated by reference numeral 10,comprises tube structure 12. Tube structure 12 comprises nasogastrictube section 14 and oropharyngeal tube section 16. The interior ofnasogastric tube section 14 is known as the lumen. Similarly, theinterior of oropharyngeal tube section 16 is known as the lumen.Nasogastric tube section 14 and oropharyngeal tube section 16 are joinedtogether at tube section 18 so as to form a generally “Y” shapedconfiguration. Tube section 18 is configured to be connected to tubesection 20. Tube section 20 is configured to be connected to an externalapparatus 21 (shown in phantom). For example, such external apparatus 21can be a suction apparatus for creating suction within tube structure12. In another example, the aforesaid external apparatus can be a foodsource for feeding a patient that is unable to feed himself or herself.

As shown in FIG. 1, nasogastric tube section 14 has a sufficient lengththat allows it to be inserted through the patient's nose 30, through thehypopharnyx region 40 (which is just below epiglottis 42) and into thepatient's stomach 50. Nasogastric tube section 14 has opening 60 that islocated in the patient's stomach 50. When tube section 20 is connectedto suction apparatus 21, the opening 60 functions as a suction intakethat effects aspiration of food contents from the stomach. As a resultof the suction, the aspirated food contents travel through nasogastrictube section 14 and into a container (not shown) in suction apparatus21. On the other hand, if tube section 20 is connected to a food source,then opening 60 functions as an output for this food.

As shown in FIG. 1, oropharyngeal tube section 16 is inserted throughthe patient's mouth 52 and has a length that is relatively shorter thanthe length of nasogastric tube section 14. Oropharyngeal tube section 16has suction intake 70. The length of oropharyngeal tube section 16 issuch that suction intake 70 is positioned in hypopharynx region 40. Whentube section 20 is connected to suction apparatus 21, suction intake 70of oropharyngeal tube section 16 sucks in microaspirations andregurgitated material located in hypopharynx region 40 thereby removingsuch microaspirations and regurgitated material from hypopharynx region40. Such microaspirations and regurgitated material travel throughoropharyngeal tube section 16 and into the aforesaid container (notshown) in suction apparatus 21. Thus, suction intake 70 substantiallyreduces the risk of infection due to aspirations from the stomach 50moving into the mouth 52.

In one embodiment, nasogastric tube section 14 and oropharyngeal tubesection 16 are fabricated from commercially available flexible, softplastic material, similar to the material used to fabricate conventionalendotracheal tubes. In one embodiment, preferably, the internal diameterof such commercial plastic tubing is between about 5 mm and 10 mm.

Referring to FIG. 2, there is shown medical apparatus 100 in accordancewith another embodiment of the present invention. Medical apparatus 100comprises tube structure 102. Tube structure 102 comprises nasogastrictube section 104, nasopharyngeal tube section 106, and tube section 108.Nasogastric tube section 104 and nasopharyngeal tube section 106 arejoined together at tube section 108 so as to form a generally “Y” shapedconfiguration. Both nasogastric tube section 104 and nasopharyngeal tubesection 106 are inserted through the patient's nose 30. Tube section 108is configured to be connected to tube section 110. Tube section 110 isconfigured to be connected to an external apparatus (not shown). Forexample, such an external apparatus can be a suction apparatus such assuction apparatus 21 described in the foregoing description. Such asuction apparatus produces suction within tube structure 102. Thus, tubesection 108 and tube section 110 have the same structure and perform thesame functions as tube section 18 and tube section 20, respectively, ofmedical apparatus 10 described in the foregoing description. Nasogastrictube section 104 has opening 160. Nasogastric tube section 104 has alength that ensures that opening 160 is positioned in the patient'sstomach 50. Nasogastric tube section 104 performs the same function asnasogastric tube section 14 (see FIG. 1). Nasopharyngeal tube section106 has suction intake 170. Nasopharyngeal tube section 106 has apredetermined length that is less than the length of nasogastric tubesection 104. This predetermined length of nasopharyngeal tube section106 allows suction intake 170 to be positioned in the patient'shypopharynx region 40. Suction intake 170 performs the same function assuction intake 70 of oropharyngeal tube section 16 shown in FIG. 1. Whenthe aforementioned suction apparatus is connected to tube section 110,suction intake 170 sucks in microaspirations and regurgitated materiallocated in hypopharynx region 40 thereby removing such microaspirationsand regurgitated material in hypopharynx region 40. Thus, suction intake170 substantially reduces the risk of infection due to aspirations fromstomach 50 moving into mouth 52.

Referring to FIGS. 3A-D, there is shown medical apparatus 300 inaccordance with a further embodiment of the present invention. Medicalapparatus 300 comprises tube structure 302 which is configured to beinserted through the patient's nose 30. Tube structure 302 comprises anouter tube 304 and an inner conduit 306. Thus, inner conduit 306 ispositioned within outer tube 304. In one embodiment, as shown in FIG.3B, inner conduit 306 is a tube having an outer surface 308. In such anembodiment, outer surface 308 is attached to inner surface 310 of outertube 304. In another embodiment, inner conduit 306 is integrally formedwith outer tube 304 during the manufacture of tube structure 302. Outertube 304 includes openings 320 and 322. The length of outer tube 304 issuch that opening 322 is located in the patient's stomach 50. Opening322 serves the same purpose as opening 60 (see FIG. 1) and opening 160(see FIG. 2). As shown in FIGS. 3A and 3C, the length of inner conduit306 is less than the length of outer tube 304. Tube structure 302 has apredetermined length that allows opening 320 to be located in thepatient's hypopharynx region 40. Inner conduit 306 includes opening 330that is aligned and in communication with opening 320 in outer tube 304.Opening 330 functions as a suction intake port or opening.

Referring to FIG. 3A, tube structure 302 has end 332. Outer tube 304 hasopening 334 that is adjacent to end 332. Inner conduit 306 has opening336 that is adjacent to end 332. Medical apparatus 300 includes tubesection 340 that is joined to end 332 of tube structure 302. Tubesection 340 serves the same purpose as tube section 20 (see FIG. 1) andis configured to be connected to an external apparatus such as suctionapparatus 21 described in the foregoing description. When a suctionapparatus is connected to tube section 340, suction is produced withintube structure 302 which results in microaspirations and regurgitatedmaterial located in hypopharynx region 40 to be sucked into opening 330.Thus, microaspirations and regurgitated material in hypopharynx region40 are removed thereby substantially reducing the risk of infection dueto aspirations from stomach 50 moving into mouth 52.

The medical apparatus shown in FIGS. 1-3D provides many importantadvantages. One such advantage is that the suction intake in hypopharynxregion 40 captures microaspirations as well as relatively largerregurgitated material and particles that enter the hypopharynx. Thisfeature reduces the risk of infection due to aspirations from thestomach moving into the mouth. This medical apparatus can be used duringsurgery for patients with any of the following conditions:

a) gastric obstruction;

b) gastroesophageal reflux disease (GERD);

c) diabetes patients who have full stomachs;

d) pregnancy (enlarged abdomens and at risk for aspiration);

e) cancer patients (poor digestion, enlarged abdominal tumors, and/orvomiting); and

f) patients on medications that increase incidence of nausea andvomiting.

This medical apparatus also can be used in the ICU (Intensive Care Unit)for (i) intubated patients who have increased risk of microaspiration inthe presence of a nasogastric tube and an endotracheal tube, such aspatients with bowel obstruction, (ii) patients with total parentalnutrition who are not intubated but require a nasogastric tube toprevent aspiration, and (iii) patients who have gastroparesis, cancer,diabetes, pregnancy and other conditions where patients have a fullstomach and require a nasogastric tube.

In accordance with another embodiment of the invention, medicalapparatus 400, shown in FIGS. 4-7, is an improved laryngeal maskapparatus configured to effect suctioning the hypopharynx region.Medical apparatus 400 comprises laryngeal mask 402 and suction tube 404.In an exemplary embodiment, laryngeal mask 402 is configured as thelaryngeal mask described in U.S. Pat. No. 4,509,514, the disclosure ofwhich patent is hereby incorporated by reference. Laryngeal mask 402 hasa front side 406 and rear side 408. Suction tube 404 is located at therear side 408 of laryngeal mask 402. In one embodiment, suction tube 404is integrally formed with laryngeal mask 402 during the manufacture ofmedical apparatus 400. In another embodiment, suction tube 404 is aseparate component that is attached to the rear side 408 of laryngealmask 400. In such an embodiment, any suitable technique can be used toattach suction tube 404 to rear side 408 of laryngeal mask 400.Laryngeal mask 402 comprises flexible breathing tube 410 and maskportion 412 with an inflatable tubular ring 414. Inflatable tubular ring414 has distal end 415. Suction tube 404 is preferably fabricated fromsoft plastics material, similar to that conventionally used forendotrachael tubes. Suction tube 404 comprises a rear side that isattached to rear side 408 of laryngeal mask 402. Suction tube 404includes front side 422. Suction tube 404 further includes tube sections430 and 440 that are joined together at middle tube section 450.Sections 430 and 440 are attached to the rear side of mask portion 412.Suction tube 404 further includes tube section 460 that is connected tomiddle tube section 450 and extends along the rear side of flexiblebreathing tube 410. Each tube section 430 and 440 has a plurality ofsuction ports 470 formed on front side 422. Suction tube 404 has endportion 480 that defines opening 482. End portion 480 is configured tobe connected to a suction hose (not shown) that is connected to anexternal suction apparatus (not shown) such as suction apparatus 21described in the foregoing description.

Referring to FIG. 7, when in use, medical apparatus 400 is inserted intothe patient's mouth 500 and down through the patient's throat 502 pastthe epiglottis 504 until mask portion 412 comes to rest with distal end415 of inflatable ring 414 in the base 506 of throat 502, lying againstthe upper end of the normally closed esophagus 508. Suction ports 470face the back of throat 502. Inflatable ring 414 is then inflated asshown to seal around inlet 514 to larynx 516. The patient's airway isthus secure and unobstructed and flexible tube 410 is then connecteddirectly to the conventional anesthetic circuit hosing for eitherpositive pressure or spontaneous breathing. End portion 480 of suctiontube 404 is then connected to a suction apparatus to allow suction ports470 to suck oropharyngeal secretions from the mouth and the back of thethroat 502. Such secretions are made not only from the patient'sstomach, but also from the salivary glands in the mouth.

Medical apparatus 400 provides a laryngeal mask with increasedversatility which can be used in many situations including patients withgastroesophageal reflux disease, gastric obstruction, diabetes with fullstomachs and cancer (e.g. poor digestion, enlarged abdomen, nausea andvomiting). The laryngeal mask of the present invention can be used bypatients during pregnancy (e.g. enlarged abdomen and at risk ofaspiration).

Referring to FIGS. 8, 9 and 10, there is shown medical apparatus 600 inaccordance with another embodiment of the invention. Medical apparatus600 is configured for the situation wherein continuous suction isnecessary. As will be shown by the ensuing discussion, medical apparatus600 prevents collapse of the hypopharynx and stomach walls whilecontinuous suctioning is occurring and also prevents damage to stomachand hypopharynx tissues. Medical apparatus 600 generally comprisesnasogastric tube structure 610. Nasogastric tube structure 610 comprisessuction tube 612 and air tube 614. Suction tube 612 and air tube 614 arejoined together at end portion 616. End portion 616 defines opening 617.Opening 617 is in communication with suction tube 612 and air tube 614.In one embodiment, the portions of suction tube 612 and air tube 614that extend from end portion 616 are attached together until they exitthe patient's body. The length of nasogastric tube structure 610 is suchthat end portion 616 is positioned in stomach 50. Suction tube 612 hassuction intakes 618. Suction tube 612 and air tube 614 separate outsideof the patient's body in order to allow these two tubes to be connectedto separate medical equipment. Suction tube 612 is joined to tubesection 620 and air tube 614 is joined to air source 622.

Medical apparatus 600 further comprises oropharyngeal tube structure630. Oropharyngeal tube structure 630 includes suction tube 632 and airtube 634 which are joined at end portion 636. End portion 636 definesopening 637. Oropharyngeal tube structure 630 includes suction intakes638. Oropharyngeal tube structure 630 has a predetermined length that isshorter than the length of tube structure 610 thereby allowing endportion 636 to be positioned in hypopharynx region 40. The portions ofsuction tube 632 and air tube 634 that extend from end portion 636 areattached together until these tubes exit the patient's body. Suctiontube 632 is joined to tube section 620. Air tube 634 is connected to airsource 640. Tube section 620 is joined to intermediate tube section 642.Intermediate tube section 642 is connected to a suction apparatus 644.Air source 622 provides air to air tube 614. This air exits air tube 614at opening 617. Air source 640 provides air to air tube 634. Such airexits air tube 634 at opening 637 in tube structure 630. Suctionapparatus 644 produces suction within suction tubes 612 and 632. As aresult of such suction, stomach contents are sucked into suction intakes618 and microaspirations and regurgitated material and particles inhypopharynx region 40 are sucked through section intakes 638. The air inair tube 614 prevents collapse of the stomach 50 and prevents suctionintakes 618 from contacting and sucking the stomach walls. Thus, damageto the tissues of the stomach wall and mucosa is prevented. Similarly,the air in air tube 634 enters hypopharynx region 40 and prevents acollapse of the hypopharynx. This air also prevents suction intakes 638from contacting and damaging the walls and tissues of the hypopharynx.

If low-level, continuous suctioning is needed in stomach 50 andhigh-level, continuous suctioning is needed in the hypopharynx, then airsource 622 can be inactivated while air source 640 continues to provideair to air tube 634. Similarly, if low-level, continuous suctioning isneeded in hypopharynx region 40 and high-level, continuous suctioning isneeded in stomach 50, then air source 622 is activated and air source640 is inactivated.

In another embodiment, nasogastric tube structure 610 is configured sothat suction tube 612, air tube 614 and end portion 616 are integralwith each other. Similarly, in another embodiment, oropharyngeal tubestructure 630 is configured so that suction tube 632, air tube 634 andend portion 636 are integral with each other. In a further embodiment,nasogastric tube structure 610 is configured so that the air tube (e.g.air tube 614) is positioned inside the suction tube (e.g. suction tube612). Similarly, in a further embodiment, oropharyngeal tube structure630 is configured so that its air tube (e.g. air tube 634) is positionedwithin the suction tube (e.g. suction tube 632).

Referring to FIGS. 11 and 12, there is shown medical apparatus 700 inaccordance with another embodiment of the invention. Medical apparatus700 is configured to be used in a situation wherein continuoushigh-level suctioning is necessary. As will be shown by the ensuingdiscussion, medical apparatus 700 prevents collapse of the hypopharynxand stomach walls while continuous suctioning is occurring and alsoprevents damage to stomach and hypopharynx tissues. Medical apparatus700 comprises outer tube 702 which is configured to be inserted eitherthrough a patient's mouth or patient's nose. Tube 702 has a distal end703 and a predetermined length that allows end 703 to be positioned in apatient's stomach. Tube 702 comprises four separate conduits 704, 706,708 and 710 which are not in communication with each other. Conduits 704and 708 are suction conduits. Conduits 706 and 710 are air conduits.Tube 702 includes suction intakes or openings 712 that are incommunication with suction conduit 704. Suction intakes 712 are locateda predetermined location along the length of tube 702 that correlates tothe hypopharynx region of a patient when tube 702 is inserted in apatient. When suction is applied to suction conduit 704,microaspirations and regurgitated material in the hypopharynx region aresucked through suction intakes 712 and up through conduit 704 and intoan external suction apparatus as will be explained in the ensuingdescription. Tube 702 includes an opening or vent 714. Air conduit 706is in communication with opening 714. When pressurized air is providedto air conduit 706, such air is vented through opening 714. The purposeof this configuration is explained in the ensuing discussion. Tube 702also includes suction intakes or openings 718. Suction conduit 708 is incommunication with suction intakes 718. When suction is applied tosuction conduit 708, stomach contents are sucked through suction intakes718 and up through suction conduit 708 and into an external suctionapparatus as will be explained in the ensuing description. As shown inFIG. 11, air conduit 710 has opening or vent 720. When pressurized airis supplied to air conduit 710, the pressurized air vents throughopening 720 and into the patient's stomach.

Referring to FIG. 11, medical apparatus 700 further comprises tubesections 730, 732, 734 and 736. Tube section 730 is joined to and incommunication with conduit 704. Tube section 732 is joined to and incommunication with conduit 706. Tube section 734 is joined to and incommunication with conduit 708. Tube section 736 is joined to and incommunication with conduit 710. Tube section 730 is configured to beconnected to suction apparatus 744. Tube section 732 is configured to beconnected to pressurized air source 742. Tube section 734 is configuredto be connected to suction apparatus 740. Tube section 736 is configuredto be connected to pressurized air source 738. Suction apparatuses 740and 744 are separate apparatuses. In one scenario, one suction apparatuscan provide high-level suction while the other suction apparatus canprovide low-level suction. In another scenario, both suction apparatusesprovide low-level suction. In a further scenario, both suctionapparatuses provide high-level suction. Pressurized air sources 738 and742 are separate air sources and each has an activated state and aninactivated state. Therefore, both pressurized air sources can beactivated or inactivated or one pressurized source activated and theother pressurized air source inactivated.

When tube 702 is inserted into a patient and high-level suction of thestomach and hypopharynx is necessary, suction apparatuses 744 and 740produce suction within suction conduits 704 and 708, respectively.Stomach contents are sucked into suction intakes 718, andmicroaspirations and regurgitated material in the hypopharynx region aresucked into suction intakes 712. All material sucked into suctionintakes 712 and 718 are sucked through conduits 704 and 708,respectively, and into baskets or other containers inside suctionapparatuses 744 and 740, respectively. In order to prevent suctionintakes 712 and 718 from damaging tissues in the hypopharynx andstomach, respectively, pressurized air sources 742 and 738 provide airto air conduits 706 and 710, respectively. The pressurized air suppliedto air conduit 706 is vented through opening 714 and the pressurized airprovided to air conduit 710 is vented through opening 720. As a result,the pressurized air vented through opening 714 keeps suction intakes 712away from hypopharynx tissue, and the pressurized air vented throughopening 720 keeps suction intakes 718 away from stomach tissue. Ifhigh-level suctioning is needed in the hypopharynx but only low-levelsuctioning is needed in the stomach, then pressurized air source 738 canbe inactivated while pressurized air source 742 remains activated.Similarly, if low-level suctioning is needed in the hypopharynx buthigh-level suctioning is needed in the stomach, then pressurized airsource 742 can be inactivated while pressurized air source 738 remainsactivated. In one embodiment, each conduit 704, 706, 708 and 710 isconfigured as a tube. In another embodiment, conduits 704, 706, 708 and710 are integrally formed with tube 702 during the manufacturingprocess.

In one embodiment, tube 702 and conduits 704, 706, 708 and 710 arefabricated from the same materials used to fabricate the tubes of themedical apparatuses described in the foregoing description.

Referring to FIGS. 13, 14A, 15 and 16-24, there is shown laryngeal maskapparatus 1000 in accordance with a further embodiment of the invention.Laryngeal mask apparatus 1000 also suctions secretions and fluids in apatient's hypopharynx region. Laryngeal mask apparatus 1000 comprisesmask or cuff portion 1001. Mask or cuff portion 1001 comprises frontside 1002, rear side 1004 and inflatable tubular ring portion 1005.Joint section 1006 is joined or attached to rear side 1004 of mask 1001.In one embodiment, joint section 1006 has a generally tubular shape.Laryngeal mask apparatus 1000 comprises flexible breathing tube 1010which is connected to joint section 1006. Flexible breathing tube 1010has interior region 1011 for the flow of air and is discussed in detailin the ensuing description. The air in flexible breathing tube 1010flows through the flexible breathing tube 1010 and through joint section1006 and into mask 1001. Mask portion 1001 has end 1007.

Laryngeal mask apparatus 1000 further comprises flexible tube 1018 thatis joined or attached to the exterior surface of flexible breathing tube1010 and extends to mask 1001. Flexible tube 1018 comprises portion1018A. A substantial portion of portion 1018A is wrapped about andjoined or attached to the exterior surface of joint section 1006. Inanother embodiment, the aforementioned substantial portion of portion1018A is joined or attached to both the exterior surface of jointsection 1006 and the rear side 1004 of mask portion 1001. In a furtherembodiment, the aforementioned substantial portion of portion 1018A isjoined or attached to rear side 1004 and positioned or wrapped aboutjoint section 1006. Portion 1018A of tube 1018 has a plurality ofsuction ports or openings 1009. Suction ports 1009 suck in the fluidsand secretions in the patient's hypopharyngeal region as will bediscussed in the ensuing description. Suction ports or openings 1009 arealso shown in FIG. 19. FIG. 19 is an enlarged view of the portion of theview of FIG. 18 that is encompassed by the dashed circle and indicatedby the number 19. As shown in FIG. 14A, tube 1018 has interior 1019which is used for suction. Suction ports or openings 1009 are incommunication with interior 1019. Tube 1018 includes air hole 1060 thatis in portion 1018A of tube 1018 and in proximity to distal end 1018C oftube 1018. Tube 1018 further includes air hole 1050 that is in portion1018B of tube 1018. Air hole 1050 functions as an air entry hole and airhole 1060 functions as an air exit hole. As shown in FIG. 15, thesection of portion 1018A that has distal end 1018C and air hole 1060 isnot joined or attached to joint section 1006 or mask 1001, but instead,is spaced part from mask 1001. This configuration ensures that air hole1060 is not blocked by any portion of mask 1001.

Additional flexible tube 1018 further comprises flexible air capillarytube 1020 that is located within interior 1019 and extends forsubstantially the entire length of tube 1018. As shown in FIG. 14C, aircapillary tube 1020 has first open end 1020A and opposite second openend 1020B. FIG. 14C shows air capillary tube 1020 in a straightconfiguration for purposes of facilitating understanding of theinvention. However, it is to be understood that air capillary tube 1020is flexible and will conform to the shape of additional flexible tube1018. First open end 1020A of air capillary tube 1020 is incommunication with air hole 1050. Opposite second open end 1020B of aircapillary tube 1020 is in communication with the air hole 1060. Whensuction is created within interior 1019, the suction pressure draws airinto air hole 1050. The air drawn into air hole 1050 enters first openend 1020A of air capillary tube 1020, flows through air capillary tube1020, exits opposite second open end 1020B of air capillary tube 1020and then exits air hole 1060. The air exiting air hole 1060 enters thepatient's hypopharyngeal region so as to decrease the direct suctionforces on the mucosa in the hypopharyngeal region. Thus, a sump functionis created by: (a) the suction within interior 1019 of tube 1018 thatdraws air into air hole 1050 and into the first open end 1020A of aircapillary tube 1020, (b) the flow of the air through the air capillarytube 1020, and (c) the flow of the air out of the second open end 1020Bof air capillary tube 1020 and out of the air hole 1060.

In one embodiment, portion 1018A is configured so that air hole 1060faces the front of the patient's throat. In another embodiment, portion1018A is configured so that air hole 1060 faces the back of thepatient's throat.

Suction tube connector 1024 is connected to portion 1018B of tube 1018.Thus, the interior of portion 1018B is in communication with theinterior of suction tube connector 1024. Suction tube connector 1024includes a suction enablement device 1025. Suction enablement device1025 includes stop member 1025A and opening 1025B. Stop member 1025A issized to be frictionally inserted into opening 1025B. Stop member 1025Amust be inserted into opening 1025B in order for suction to take placethrough interior 1019 of tube 1018. Thus, if a suction producing deviceis connected to suction tube connector 1024, suction through interior1019 will not occur unless stop member 1025A is plugged into opening1025B. Such a configuration ensures that the patient's throat or mouthis not over-suctioned. The stop member 1025A is inserted into or removedfrom opening 1025B by medical personnel. When stop member 1025A isinserted into opening 1025B and a suction producing apparatus isconnected to suction tube connector 1024, suction will be createdthroughout interior 1019 of tube 1018 which causes secretions and fluidsto be sucked in through suction ports 1009. Suction within interior 1019of tube 1018 causes air to be drawn into air hole 1050. As described inthe foregoing description, the air that is drawn into the air hole 1050then flows through air capillary tube 1020, exits air hole 1060 and thenenters the area being suctioned so as to provide gentle but efficientsuction without damaging the mucosa. Thus, the flow of air exiting airhole 1060 prevents suction ports 1009 from sticking to and sucking themucosa. Such a configuration prevents trauma to and bleeding of themucosa.

Referring to FIG. 14A, in one embodiment, flexible breathing tube 1010is formed with a longitudinally extending protruding portion 1040 whichhas curved surface 1042. Tube 1018 is joined or attached to curvedsurface 1042 by any suitable technique, e.g. adhesive, heat treatment,etc. In another embodiment, tube 1018 is integrally formed with flexiblebreathing tube 1010. Referring to FIG. 14B, there is shown an alternateembodiment wherein flexible breathing tube 1010 and tube 1018 arereplaced by flexible breathing tube 1200 and flexible tube 1220,respectively. Flexible breathing tube 1200 performs the same function asflexible breathing tube 1010 but has a different structure. Flexiblebreathing tube 1200 has interior 1202 and a substantially circularcross-section. Flexible tube 1220 performs the same function as tube1018. Tube 1220 is joined or attached to the exterior surface offlexible breathing tube 1200 by any suitable technique, e.g. adhesive,heat treatment, etc. In one embodiment, tube 1220 is integrally formedwith flexible breathing tube 1200. Tube 1220 has an interior 1230 whichprovides the same function as interior 1019 of tube 1018. Tube 1220 hasair entry and air exit holes that perform the same functions as airholes 1050 and 1060, respectively. A flexible air capillary tube 1240 ispositioned within tube 1220. Air capillary tube 1240 has the samestructure and performs the same function as air capillary tube 1020. Aircapillary tube 1240 has interior 1250.

Referring to FIGS. 15 and 16, laryngeal mask apparatus 1000 includesmouthpiece connector 1026 that is configured to be connected to aventilating system which provides air, oxygen and anesthesia gases.Mouthpiece 1026 comprises portion 1028 that is configured and sized tobe frictionally inserted into the opening of flexible breathing tube1010. Mouthpiece 1026 further comprises portion 1030 that is configuredto be connected to the ventilating system. Mouthpiece 1026 furthercomprises flange portion 1032 that separates portions 1028 and 1030 andabuts the end of flexible breathing tube 1010 when portion 1028 iscompletely inserted into the opening of the flexible breathing tube1010.

Referring to FIGS. 15, 17, 18 and 24, laryngeal mask apparatus 1000further comprises air tube 1012 that is connected to mask 1001.Laryngeal mask apparatus 1000 further comprises pilot valve 1014 whichis connected to air tube 1012, and connector 1016 that is connected topilot valve 1014. Connector 1016 is configured to be connected to an airsource which provides an air stream that inflates tubular ring 1005 ofmask portion 1001. The pilot valve 1014 controls the amount of air thatpasses through air tube 1012 and into tubular ring 1005.

When in use, laryngeal mask apparatus 1000 is inserted into thepatient's mouth and down through the patient's throat past theepiglottis until mask portion 1001 comes to rest with end 1007 of maskportion 1001 positioned in the base of the patient's throat, lyingagainst the upper end of the normally closed esophagus. Suction ports1009 face the back of the throat. Inflatable ring 1005 is then inflatedvia air tube 1012 and valve 1014 to seal the area around the inlet tothe larynx. The patient's airway is thus secure and unobstructed andflexible breathing tube 1010 is then connected directly to theconventional anesthetic circuit hosing for either positive pressure orspontaneous breathing. Suction connector 1024 is then connected to asuction producing apparatus and stop member 1025A is inserted intoopening 1025B to allow suction ports 1009 to suck oropharyngealsecretions from the mouth and the back of the patient's throat. Suchsecretions are made not only from the patient's stomach, but also fromthe salivary glands in the mouth. Air holes 1050 and 1060 of tube 1018cooperate with air capillary tube 1020 to ensure that the suction atsuction ports 1009 does not damage the mucosa.

Referring to FIGS. 25-34, there is shown laryngeal mask apparatus 2000in accordance with a further embodiment of the invention. Laryngeal maskapparatus 2000 has generally the same structure as laryngeal mask 1000except laryngeal mask apparatus 2000 includes scope tube 2500. Scopetube 2500 includes scope funnel 2550. A gastric tube may be insertedthrough scope funnel 2550 and scope tube 2500 in order to suck outstomach regurgitation and microaspirations thereby decreasing the riskof such regurgitation and microaspirations from entering the lungs ormouth. Scope tube 2500 and scope funnel 2550 are discussed in detail inthe ensuing description. Laryngeal mask apparatus 2000 further comprisesmask or cuff portion 2001. Mask or cuff portion 2001 comprises frontside 2002, rear side 2004 and inflatable tubular ring portion 2005. Mask2001 includes inner spatial region 2005A that is surrounded byinflatable tubular ring portion 2005. Mask 2001 includes end portion2007. End portion 2007 is part of inflatable tubular ring portion 2005.Mask 2001 includes opening or port 2008 that is in end 2007. Opening orport 2008 extends through inflatable tubular ring portion 2005 and is incommunication with spatial region 2005A. The purpose of opening or port2008 is described in detail in the ensuing description.

Joint section 2006 is joined or attached to rear side 2004 of mask 2001.In an exemplary embodiment, joint section 2006 has a generally tubularshape. Laryngeal mask apparatus 2000 further includes flexible breathingtube 2010 which is connected to joint section 2006. As shown in FIG. 35,flexible breathing tube 2010 has interior region 2011 for the flow ofair and is discussed in detail in the ensuing description. The air inflexible breathing tube 2010 flows through the flexible breathing tube2010 and through joint section 2006 and into mask 2001. Laryngeal maskapparatus 2000 further comprises flexible tube 2018 that is joined orattached to the exterior surface of flexible breathing tube 2010 andextends to mask 2001. Flexible tube 2018 has the same structure,configuration and function as flexible tube 1018 of laryngeal maskapparatus 1000. Flexible tube 2018 comprises portion 2018A. Asubstantial portion of portion 2018A is wrapped about and joined orattached to the exterior surface of joint section 2006. In anotherembodiment, the aforementioned substantial portion of portion 2018A isjoined or attached to both the exterior surface of joint section 2006and the rear side 2004 of mask portion 2001. In a further embodiment,the aforementioned substantial portion of portion 2018A is joined orattached to rear side 2004 and positioned or wrapped about joint section2006. Portion 2018A of tube 2018 has a plurality of suction ports oropenings 2009. Suction ports 2009 suck in the fluids and secretions inthe patient's hypopharyngeal region as will be discussed in the ensuingdescription. Tube 2018 has interior 2019 which is used for suction (seeFIG. 35). Suction ports or openings 2009 are in communication withinterior 2019. Tube 2018 includes air hole 2060 that is in portion 2018Aof tube 2018 and in proximity to distal end 2018C of tube 2018 (see FIG.30). Tube 2018 further includes air hole 2050 that is in portion 2018Bof tube 2018. Air hole 2050 functions as an air entry hole and air hole2060 functions as an air exit hole. As shown in FIGS. 29 and 30, thesection of portion 2018A that has distal end 2018C and air hole 2060 isnot joined or attached to joint section 2006 or mask 2001, but instead,is spaced part from mask 2001. This configuration ensures that air hole2060 is not blocked by any portion of mask 2001.

Flexible tube 2018 further comprises flexible air capillary tube 2020that is located within interior 2019 and extends for substantially theentire length of tube 2018 (see FIG. 35). Air capillary tube 2020 hasthe same structure, configuration, purpose and function as air capillarytube 1020 of laryngeal mask apparatus 1000. Air capillary tube 2020 hasa first open end in communication with air-hole 2050 and an oppositesecond open end in communication with air hole 2060. When suction iscreated within interior 2019, the suction pressure draws air into airhole 2050. The air drawn into air hole 2050 enters the first open end ofair capillary tube 2020, flows through air capillary tube 2020, exitsthe opposite second open end of air capillary tube 2020 and flows out ofair hole 2060. The air exiting air hole 2060 enters the patient'shypopharyngeal region so as to decrease the direct suction forces on themucosa in the hypopharyngeal region. Thus, a sump function is createdby: (a) the suction within interior 2019 of tube 2018 that draws airinto air hole 2050 and into air capillary tube 2020, (b) the flow of theair through the air capillary tube 2020, and (c) the flow of the air outof air capillary tube 2020 via air hole 2060. In one embodiment, portion2018A is configured so that air hole 2060 faces the front of thepatient's throat. In another embodiment, portion 2018A is configured sothat air hole 2060 faces the back of the patient's throat. Suction tubeconnector 2024 is connected to portion 2018B of tube 2018. Thus, theinterior of portion 2018B is in communication with the interior ofsuction tube connector 2024. Suction tube connector 2024 includes asuction enablement device 2025. Suction enablement device 2025 includesstop member 2025A and opening 2025B. Stop member 2025A is sized to befrictionally inserted into opening 2025B (see FIG. 29). Stop member2025A must be inserted into opening 2025B in order for suction to takeplace through interior 2019 of tube 2018. Thus, if a suction producingdevice is connected to suction tube connector 2024, suction throughinterior 2019 will not occur unless stop member 2025A is plugged intoopening 2025B. Such a configuration ensures that the patient's throat ormouth is not over-suctioned. The stop member 2025A is inserted into orremoved from opening 2025B by medical personnel. When stop member 2025Ais inserted into opening 2025B and a suction producing apparatus isconnected to suction tube connector 2024, suction will be createdthroughout interior 2019 of tube 2018 which causes secretions and fluidsto be sucked in through suction ports 2009. Suction within interior 2019of tube 2018 causes air to be drawn into air hole 2050. As described inthe foregoing description, the air that is drawn into the air hole 2050then flows through air capillary tube 2020, exits air hole 2060 and thenenters the area being suctioned so as to provide gentle but efficientsuction without damaging the mucosa. Thus, the flow of air exiting airhole 2060 prevents suction ports 2009 from sticking to and sucking themucosa. Such a configuration prevents trauma to and bleeding of themucosa.

Scope tube 2500 is joined or attached to the exterior of flexiblebreathing tube 2010. In an exemplary embodiment, scope tube 2500 isjoined or attached to the dorsal part or portion of flexible breathingtube 2010. Scope tube 2500 includes end portion 2502 that is joined orattached to joint section 2006 and an opposite end to which is attachedscope funnel 2550. Scope tube 2500 has an interior region and an innertube 2510 that is disposed within and extends throughout the interiorregion of scope tube 2500. The configuration of scope tube 2500 and themanner in which end portion 2502 is joined to joint section 2006 allowsinner tube 2510 to extend throughout the interior region of scope tube2500 and through spatial region 2005A of mask 2001 and into opening orport 2008. The portion of inner tube 2510 that extends through spatialregion 2005A and into opening or port 2008 is indicated by referencenumber 2510A. Inner tube 2510 includes interior 2512 for the flow ofair, liquids, regurgitated material or particulate. The interior 2512 isnot in communication with the interiors of flexible breathing tube 2010or joint section 2006. This means that fluid, microaspirations orregurgitated material flowing through interior 2512 of inner tube 2510never enters the interiors of joint section 2006 or flexible breathingtube 2010.

Referring to FIG. 35, in an exemplary embodiment, flexible breathingtube 2010 is formed with a first longitudinally extending protrudingportion 2040 which has concave surface 2042 and a second longitudinallyextending protruding portion 2044 which has a concave surface 2046. Tube2018 is joined or attached to concave surface 2042 by any suitabletechnique, e.g. adhesive, heat treatment, etc. Similarly, scope tube2500 is joined or attached to concave surface 2046 by any suitabletechnique, e.g. adhesive, heat treatment, etc. In an exemplaryembodiment, the adhesive used is a silicone adhesive. In anotherembodiment, tube 2018 and scope tube 2500 are integrally formed withflexible breathing tube 2010.

Laryngeal mask apparatus 2000 further includes mouthpiece connector 2026that is attached to the opening of flexible breathing tube 2010.Mouthpiece connector 2026 is configured to be connected to a ventilatingsystem which provides air, oxygen and anesthesia gases. Mouthpiece 2026has the same purpose, function, structure and configuration asmouthpiece 1026 of laryngeal mask apparatus 1000 and is therefore notdescribed in detail.

Laryngeal mask apparatus 2000 further comprises air tube 2012 that isconnected to mask 2001. Laryngeal mask apparatus 2000 further comprisespilot valve 2014 that is connected to air tube 2012, and connector 2016that is connected to pilot valve 2014. Connector 2016 is configured tobe connected to an air source which provides an air stream that inflatestubular ring 2005 of mask portion 2001. The pilot valve 2014 controlsthe amount of air that passes through air tube 2012 and into inflatabletubular ring 2005. Air tube 2012, pilot valve 2014 and connector 2016have the same purpose, function, structure and configuration as air tube1012, pilot valve 1014 and connector 1016, respectively, of laryngealmask apparatus 1000.

When in use, laryngeal mask apparatus 2000 is inserted into thepatient's mouth and down through the patient's throat past theepiglottis until mask portion 2001 comes to rest with end 2007 of maskportion 2001 positioned in the base of the patient's throat, lyingagainst the upper end of the normally closed esophagus. Suction ports2009 face the back of the throat. Inflatable ring 2005 is then inflatedvia air tube 2012 and valve 2014 to seal the area around the inlet tothe larynx. The patient's airway is thus secure and unobstructed andflexible breathing tube 2010 is then connected directly to theconventional anesthetic circuit hosing for either positive pressure orspontaneous breathing. Suction connector 2024 is then connected to asuction producing apparatus and stop member 2025A is inserted intoopening 2025B to allow suction ports 2009 to suck oropharyngealsecretions from the mouth and the back of the patient's throat. Suchsecretions are made not only from the patient's stomach, but also fromthe salivary glands in the mouth. Air holes 2050 and 2060 of tube 2018cooperate with air capillary tube 2020 to ensure that the suction atsuction ports 2009 does not damage the mucosa. In order to aspiratecontents or particulate from the patient's stomach, a gastric tube 2600is inserted into scope funnel 2550 and into scope tube 2500. The gastrictube 2600 extends through inner tube 2510 and through portion 2510A ofinner tube 2510 and then through opening 2008 and into the patient'sstomach. The gastric tube 2600 is then connected to a suction producingdevice in order to suction the stomach. Suctioning the stomach in thismanner decreases the risk of any stomach regurgitation andmicroaspirations from entering the lungs or mouth. The gastric tube 2600may be connected to the same suction producing device to which suctionconnector 2024 is connected. Alternatively, the gastric tube 2600 may beconnected to a separate suction producing device. Thus, laryngeal maskapparatus 2000 sucks regurgitation and microaspirations from thestomach, mouth, pharynx and hypopharynx simultaneously so as to reducethe risk of infection caused by stomach aspirations and regurgitationsfrom passing into the patient's stomach and lungs.

Laryngeal mask apparatuses 1000 and 2000 may be configured in differentsizes for use with patients of various sizes, e.g. infants, children,adults, etc.

The foregoing description, for purpose of explanation, has beendescribed with reference to specific embodiments. However, theillustrative discussions above are not intended to be exhaustive or tolimit the invention to the precise forms disclosed. Furthermore, manymodifications and variations in materials, dimensions, shapes andcross-sectional geometries are possible in view of the above teachings.The embodiments were chosen and described in order to best explain theprinciples of the invention and its practical applications so as tothereby enable others skilled in the art to best utilize the inventionand various embodiments with various modifications as are suited to theparticular use contemplated.

What is claimed is:
 1. A laryngeal mask apparatus (2000) comprising: amask (2001) comprising a front side (2002) and a rear side (2004) thatfaces a back of a patient's throat when the mask (2001) is positionedwithin the patient's throat, the mask (2001) including an inflatabletubular ring (2005) and an inner spatial region (2005A) that issurrounded by the inflatable tubular ring (2005), the mask (2001) havinga front end (2007) and an opening (2008) in the front end (2007) whichextends through the inflatable tubular ring (2005) and is incommunication with the inner spatial region (2005A); an air tube (2012)that is connected to the inflatable tubular ring (2005) and adapted tobe connected to an air source so as to allow inflation of the inflatabletubular ring (2005); a joint section (2006) attached to the rear side(2004) of mask (2001) and having an exterior surface; a flexiblebreathing tube (2010) connected to the joint section (2006), theflexible breathing tube (2010) having an interior (2011) for the flow ofair therethrough and an exterior surface, wherein air in the flexiblebreathing tube (2010) flow through the flexible breathing tube (2010)and through the joint section (2006) and into the mask (2001); aconnector (2026) having a first portion inserted into the flexiblebreathing tube (2010) and a second portion configured for connection toa ventilating system; an additional flexible tube (2018) attached to theexterior surface of the flexible breathing tube (2010) and comprising aninterior (2019), a first portion (2018A) and a second portion (2018B)that is configured to be connected to a suction producing device thatproduces suction within the interior (2019), wherein a substantialportion of the first portion (2018A) is wrapped about and attached tothe exterior surface of joint section (2006), wherein the additionalflexible tube (2018) extends to a distal end (2018C) which is part of asection of the first portion (2018A), the first portion (2018A) having aplurality of suction ports (2009) in communication with the interior(2019), the suction ports (2009) being located in the first portion(2018A) such that the suction ports (2009) face the back of thepatient's throat when the mask (2001) is positioned within the patient'sthroat so that the suction ports (2009) suck in fluids and secretions inthe patient's hypopharyngeal region when suction is created within theinterior (2019), the additional flexible tube (2018) further comprisingan air entry hole (2050) in the second portion (2018B) and an air exithole (2060) in the first portion (2018A), wherein the part of thesection of the first portion (2018A) having the distal end (2018C) andthe air exit hole (2060) is not attached to the exterior surface of thejoint section (2006) or the mask (2001) but is spaced apart from themask (2001) to ensure that the air exit hole (2060) is not blocked byany portion of the mask (2001); the additional flexible tube (2018)including a flexible air capillary tube (2020) that is positioned withinthe interior (2019) of the additional flexible tube (2018) and whichextends for substantially an entire length of the additional flexibletube (2018), the air capillary tube (2020) having a first open end incommunication with the air entry hole (2050) and an opposite second openend in communication with the air exit hole (2060), wherein when suctionis created within the interior (2019), air is drawn into the air entryhole (2050) and enters the first open end of the air capillary tube(2020) wherein the air then flows through the air capillary tube (2020),exits the opposite second open end and then exits the air exit hole(2060), such that when the mask (2001) is positioned within thepatient's throat and suction is created within the interior (2019), theair exiting the air exit hole (2060) decreases the direct suction forceson a mucosa of the patient's throat that are caused by the suction ports(2009); a suction tube connector (2024) connected to the additionalflexible tube (2018) and configured to be connected to a suctionproducing device; a scope tube (2500) attached to the exterior surfaceof the flexible breathing tube (2010) and having a first end that isattached to the joint section (2006) and an opposite second end, thescope tube (2500) including an interior and an inner tube (2510) that isdisposed within the interior of the scope tube (2500), the inner tube(2510) extending throughout the scope tube (2500) and the inner spatialregion (2005A) and being joined to the opening (2008) in the front end(2007) of the mask (2001), wherein the flexible breathing tube (2010)comprises an extension (2044) along a length of the flexible breathingtube (2010), wherein the extension (2044) comprises a concave surface(2046), the entire concave surface (2046) is configured to contact anouter surface of the scope tube (2500), and wherein the scope tube(2500) extends for an entire length of the concave surface (2046); and agastric tube (2600) extending through the inner tube (2510) and throughthe opening (2008) that is in the end (2007) of the mask (2001).
 2. Thelaryngeal mask apparatus (2000) according to claim 1 wherein the scopetube (2500) further includes a scope funnel (2550) attached to theopposite second end of the scope tube (2500), the scope funnel (2550)being shaped to facilitate insertion therein of the gastric tube (2600).3. The laryngeal mask apparatus (2000) according to claim 1 wherein thefirst portion (2018A) of the additional flexible tube (2018) is alsoattached to rear side (2004) of mask (2001).
 4. The laryngeal maskapparatus (2000) according to claim wherein the suction tube connector(2024) further comprises a suction enablement device (2025) to enablecreation of suction within the interior (2019) of the additionalflexible tube (2018).